On October 26 the FDA panel of doctors voted 17-0 to recommend the EUA (Emergency Use Authorization) of the Pfizer-BioNTech COVID-19 Vaccine for children aged 5-11:
“After a full day of presentations and discussions, the group voted 17-0 with one abstention to recommend emergency use authorization (EUA) of the vaccine for 5- to 11-year-olds. The decision to grant an EUA now goes to the FDA commissioner. The Centers for Disease Control and Prevention’s (CDC’s) vaccine advisory committee will meet Nov. 2-3 to discuss who should receive the vaccine.”
On October 29, the FDA approved the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine for children aged 5-11. (FYI, there is no Covid-19 “vaccine” that is APPROVED and available for use in the USA by the FDA, just the EMERGENCY USE of a “vaccine”)
However, the October 29 FDA announcement linked above shows that just 3 days AFTER the members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted in favor of the EUA and AFTER all the clinical trials that were done, on October 29 as part of the FDA’s EUA approval, there was a manufacturing change to the formulation to switch out PBS (phosphate-buffered saline) to the drug Tris (tromethamine):
“On October 29, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under Section 564(g)(2) of the Act, FDA is again reissuing the October 20, 2021 letter of authorization in its entirety with revisions incorporated to:
1) authorize the use of Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age; and
2) authorize a manufacturing change to include an additional formulation of the Pfizer-BioNTech COVID-19 Vaccine that uses tromethamine (Tris) buffer instead of phosphate buffered saline (PBS) used in the originally authorized Pfizer-BioNTech COVID-19 Vaccine.” The same announcement then follows in fine print with:
“The Pfizer-BioNTech COVID-19 Vaccine (0.2 mL dose containing 10 μg modRNA) that uses Tris buffer and is available in multiple dose vials with orange caps and labels with an orange border is the only formulation that is authorized for use in individuals 5 through 11 years of age.”
Finally, the October 29th FDA approval announcement demonstrates that NO clinical testing was done using the new Tris formulation:
For the October 29, 2021 authorization of the manufacturing change to include an additional formulation of the Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer instead of PBS buffer used in the originally authorized Pfizer-BioNTech COVID-19 Vaccine, FDA reviewed data on analytical comparability, which uses laboratory testing to demonstrate that a change in product formulation is not expected to impact safety or effectiveness. In the case of PfizerBioNTech COVID-19 Vaccine, multiple different release parameters were evaluated, ranging from product appearance to size of the lipid-nanoparticle to the integrity of the modRNA in the product. Characterization testing included looking at product composition and purity including characteristics of the modRNA, and strength including the lipid-nanoparticle size distribution and shape, as these are characteristics associated with the activity of the vaccine. In this case, analytical comparability to the current PBS formulation of the Pfizer-BioNTech COVID-19 Vaccine was demonstrated for the Tris formulation of the Pfizer-BioNTech COVID-19 Vaccine through a combination of release and characterization testing.
According to the New England Journal of Medicine regarding Tris,the drug has also been proposed as a more effective buffer than bicarbonate for the treatment of metabolic acidosis…”
Penn Medicine has also weighed in regarding metabolic acidosis, “Most symptoms are caused by the underlying disease or condition that is causing the metabolic acidosis. Metabolic acidosis itself most often causes rapid breathing. Acting confused or very tired may also occur. Severe metabolic acidosis can lead to shock or death. In some situations, metabolic acidosis can be a mild, ongoing (chronic) condition.”
And according to The Memorial Sloan Kettering Cancer Center regarding taking Tris/Tham: “What do I need to tell the doctor BEFORE my child takes this drug?
- If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
- If your child has a high urea level in the blood or is not able to pass urine.
- If the patient is a newborn who has any of these health problems: High blood carbon dioxide levels or too much salicylate in the body.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe to give this drug with all of your child’s other drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Check your child’s blood sugar as you have been told by the doctor…..
…. What are some side effects that I need to call my child’s doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
- Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
- Trouble breathing, slow breathing, or shallow breathing.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- This drug may cause tissue damage if the drug leaks from the vein. Tell your child’s nurse if your child has any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your child’s body.”
Additional excerpts from the aforementioned AAP article found at
- Since the start of the pandemic, about 9 million children ages 5-11 years have been infected, about 9% of all U.S. cases. More than 8,300 have been hospitalized and 94 have died, according to federal data.
- Mark H. Sawyer, M.D., FAAP, professor of clinical pediatrics in the Division of Infectious Diseases at the University of California San Diego School of Medicine, noted myocarditis historically is less common in this age group than in older groups and more data won’t be available until the vaccine is more widely used.
- Cody Meissner, M.D., FAAP, chief of the Division of Pediatric Infectious Disease at Tufts Medical Center, noted that CDC data show about 42% of children may have had COVID-19, which he said likely means they have some protection. “We’re getting down to a very small percent of otherwise healthy (5)- to 11-year-old children who might derive some benefit, and we simply don’t know what the side effects are going to be,” Dr. Meissner said.
- …Patrick S. Moore, M.D., M.P.H., professor in the Department of Microbiology and Molecular Genetics at the University of Pittsburgh School of Medicine. “If surveillance systems do start seeing severe outcomes and deaths from vaccination, I’m quite confident those surveillance systems will tell us we need to pause like we did with the J&J (Johnson & Johnson) vaccine.”
- Under a plan released by the White House last week, PEDIATRICIANS will be on the front lines of vaccinating children.
Questions brought to mind from these excerpts:
- If (albeit very unfortunate) 94 deaths have occurred in this age range out of the 1.9 million infected (0.00005 %), why is this considered an emergency for this age range?
- Why did Pfizer use PBS as the buffer through all the clinical studies, then were allowed to change the formulation to Tris AFTER the FDA panel voted to approve the vaccine for EUA and NOT have to perform completely new clinical trials?
- Shouldn’t the FDA restart ALL clinical studies using the new formulation of the vaccine that includes Tris as the buffer and remove the EUA approval immediately?
- If pediatricians are recommending the vaccine for children 5-11 years of age and the vaccine now contain a DRUG (tris) that comes with its own list of precautions, shouldn’t pediatricians have to confirm typical drug prescription screenings to make sure each individual should be receiving Tris as part of the vaccine?
- Are pediatricians making sure every parent knows about the change in the formulation to the 5-11-year-old vaccine and letting them know that this is ONLY age group that HAS to have Tris in the formulation?